http://www.fda.gov/cder/orange/appendix_a.txt
2, BUTABARBITAL SODIUM SARISOL, BUTABARBITAL SODIUM APPENDIX A PRODUCT NAME INDEX SATRIC, METRONIDAZOLE SCABENE, LINDANE SCANDONEST L, LEVONORDEFRIN SCANDONEST PLAIN, MEPIVACAINE HYDROCHLORIDE SCLEROSOL, TALC SCRUBTEAM SURGICAL SPONGEBRUSH, HEXACHLOROPHENE SEASONALE, ETHINYL ESTRADIOL SECOBARBITAL SODIUM, SECOBARBITAL SODIUM SECONAL SODIUM, SECOBARBITAL SODIUM SECREFLO, SECRETIN...
Prescription and OTC Drug Product List 11/2001
IRRIGANT -D- MONARCH PHARMS EQ 40MG BASE/ML;200,000 UNITS/ML N60707 001 JUN 28, 1966 NOV CRLD -A- + EQ 40MG BASE/ML;200,000 UNITS/ML N60707 001 JUN 28, 1966 NOV CRLD OMEPRAZOLE CAPSULE, DELAYED REL PELLETS; ORAL -A- OMEPRAZOLE -A- AB ANDRX PHARMS 10MG N75347 001 NOV 16, 2001 NOV NEWA -A- AB 20MG N75347 002 NOV 16, 2001 NOV NEWA -A- AB 40MG N75347 003 NOV 16, 2001 NOV NEWA -A-...
FDA Drug Approvals List February 2000
- Drug Approvals for February 2000 Definitions and Notes Original New Drug Applications Original Application #: 021015 Approval Date: 28-FEB-00 Trade Name: ANDROGEL Chemical Type: 3 Therapeutic Potential: S Dosage Form: GEL Applicant: UNIMED PHARMACEUTICALS INC Active Ingredient(s): TESTOSTERONE OTC/RX Status: RX Indication(s): For replacement therapy in males for conditions...
Prescription and OTC Drug Product List 5/2001
IRRIGANT NYSTATIN - ADD - MONARCH PHARMS EQ 40MG BASE/ML; - ADD - @ TEVA 100,000 UNITS/GM N61966 001 - ADD - 200,000 UNITS/ML N60707 001 OINTMENT; TOPICAL - DLT - NILSTAT NETILMICIN SULFATE - DLT - AT + LEDERLE 100,000 UNITS/GM N61444 001 - ADD - @ 100,000 UNITS/GM N61444 001 - DLT - INJECTABLE; INJECTION NYSTATIN - DLT - NETROMYCIN - DLT - AT ALTANA 100,000 UNITS/GM N62124 002 - DLT...
THE MERCK MANUAL, Sec. 13, Ch. 153, Antibacterial Drugs
This Publication Is Searchable The Merck Manual of Diagnosis and Therapy--- Section 13. Indications Sulfonamides are currently used in UTI, in nocardiosis, in combination with pyrimethamine in the treatment of toxoplasmosis, as a substitute for penicillin in prophylaxis of rheumatic fever, as prophylaxis against susceptible meningococcal strains, in ulcerative colitis (as...
Worthington Collagenase
Purification and Properties, Biochem 12, 1814, 1973 - Eisen, A., Jeffrey, J., and Gross, J.: Human Skin Collagenase, Isolation and Mechanism of Attack on the Collagen Molecule, Biochim Biophys Acta 151, 637, 1968 - Ellis, S., Nabeshima, K., and Biswas, C.: Monoclonal Antibody Preparation and Purification of a Tumor Cell Collagenase-Stimulatory Factor, Cancer Res 49, 3385, 1989 -...
Worthington Glucose Oxidase
Demonstration of an Obligatory Pathway Involving an External Circuit for the Enzymatically Catalyzed Aerobic Oxidation of Glucose, Arch Biochem Biophys 169, 146, 1975 - Weibel, M., Dritschild, W., Bright, H., and Humphrey, A.: Immobilized Enzymes: A Prototype Apparatus for Oxidase Enzymes in Chemical Analysis Utilizing Covalently Bound Glucose Oxidase, Anal Biochem 52, 402, 1973 -...
Uses For Collagenase?
Uses for Collagenase Dupuytrens Disease Peyronies Disease Glaucoma Wound Healing Dermal Ulcers Burns Bibliography Dupuytrens Disease This is a deforming condition of the hand in which one or more fingers, usually the ring finger and little finger, contract toward the palm, often resulting in functional disability. Stage III:...
Paragraph IV Patent Certifications
- DRUG NAME DOSAGE FORM STRENGTH RLD Acetaminophen Extended-release Tablets 650 mg Tylenol Acetaminophen/ Aspirin/ Caffeine Tablets 250 mg/250 mg/ 65 mg Excedrin (migraine) Acetaminophen and Tramadol Hydrochloride Tablets 325 mg/ 37.5 mg Ultracet Acyclovir Sodium1 Injection 50 mg/mL, 10 mL and 20 mL vials Zovirax Albuterol Sulfate Oral Syrup 2 mg(base)/ 5 mL Ventolin Albuterol...
THE MERCK MANUAL, Sec. 13, Ch. 153, Antibacterial Drugs
This Publication Is Searchable The Merck Manual of Diagnosis and Therapy--- Section 13 Indications Sulfonamides are currently used in UTI, in nocardiosis, in combination with pyrimethamine in the treatment of toxoplasmosis, as a substitute for penicillin in prophylaxis of rheumatic fever, as prophylaxis against susceptible meningococcal strains, in ulcerative colitis (as...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt
LISINOPRIL CRUDE AS MFG IN COURBEVOIE AND HAM FRANCE 14537 19-Nov-99 FUJISAWA PHARMACEUTICAL CO LTD FK8453 DRUG SUBSTANCE AS MFG IN HYOGO AND OSAKA JAPAN 14538 09-Nov-99 SICOR DE MEXICO SA DE CV AMCINONIDE AS MFG IN LERMA MEXICO 14539 18-Nov-99 "UQUIFA ITALIA, S.P.A." CLINDAMYCIN HYDROCHLORIDE USP AS MFG IN MILAN ITALY 14540 18-Nov-99 DIOSYNTH BV TESTOSTERONE UNDECANOATE AS MFG IN...
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls
Arthur Shaw CDER User $ ($) $ ($) $ ($) $ ($) $ $ () $ - () - $ $ () $ - () - -- -- $ ($) $ ($) $ ($) $ ($) / / // -- - - : : :: : () () () () () - $ $ () $ - () - $ $ () $ - : :: : 4Q2003 TYPE2ACTIVEEXCEL DMF # SUBMIT DATE HOLDER SUBJECT CENTRAL SOYA SOYBEAN STEROL PRODUCTS INTERNATIONAL SPECIALTY PRODUCTS POLYVINYL PYRROLIDONE-IODINE 10 MALLINCKRODT CHEMICAL INC PARZONE BITARTRATE ...
LIST OF APPROVED DRUGS FOR WHICH ADDITIONAL PEDIATRIC INFORMATION
DOCKET NO Anti-Infective Drug Products Ampicillin/sulbactam Skin/skin structure infections and intraabdominal infections Anesthetic, Critical Care And Addiction Drug Products Bupropion Treatment of depression Metabolic And Endocrine Drug Products Dexmedetomidine Sedation of initially intubated and mechanically ventilated patients in an ICU setting Prolonging the time to...
Extended prescribing of prescription medicines by Nurse prescribers
Anne Ryan Medicines Control Agency 16 Market Towers 1 Nine Elms Lane London SW8 5NQ Dear Ms Ryan CONSULTATION ON THE EXTENDED PRESCRIBING OF PRESCRIPTION ONLY MEDICINES BY INDEPENDENT NURSE PRESCRIBERS MLX 273 Thank you for the opportunity to comment on the proposals to extend the range of prescription only medicines (POMs) that may be prescribed by independent nurse prescribers
Extended prescribing of prescription medicines by Nurse prescribers page 6
Comprehensive List of Current Guidance Documents at the Food and Drug Administration page 30
author: FDA
Quarterly List of Guidance Documents at the Food and Drug Administration page 11
author: FDA
http://www.cigb.edu.cu/Publicaciones/Human%20recombinant%20epidermal%20crowth%20factor%20in%20the%20treatment%20Of%20radiogenic%20ulcers.pdf page 1
Prescription and OTC Drug Product List 12/1998
Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 12: December 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST - ADD - ABACAVIR SULFATE ALBUTEROL SULFATE - ADD - SOLUTION; ORAL SOLUTION; INHALATION - ADD - ZIAGEN ALBUTEROL SULFATE - ADD - + GLAXO WELLCOME EQ 20MG BASE/ML N20978 001 - ADD - @ COPLEY PHARM...
may20lst.PDF
Docket No 98N- 0056 May 20, 1998 Page 6 Drug Name Potential pediatric use limited to approved indications Age Group In Which More Information Needed birth to 1 mos 1 mos to 2 yrs 2 to 12 years 12 to 16 years Milrinone Treatment of heart failure Yes Yes Yes Yes Minoxidil Hypertension Yes Yes Yes Yes Moexipril Hypertension Yes Yes Yes Yes Moexipril/ Hydrochlorothiazide Hypertension...
author: Unknown
may20lst.PDF page 16
author: Unknown
http://www.fda.gov/cber/gdlns/guidelst.txt
Drug Advertising and Promotional Labeling DDMAC 2 Dissemination of Reprints of Certain October 8, 1996 Advertising Do Published, Original Data Funded Dissemination of Reference October 8, 1996 Do Do Texts Antifungal (topical) February 24, 1990 Biopharmaceutic Drug Information Branch (Draft) Antifungal (vaginal) February 24, 1990 Do Do Food-Effect Bioavailability and December 30, 1997...
http://www.cigb.edu.cu/Publicaciones/Progress%20in%20clinical%20application%20of%20EGF%20in%20Cuba.PDF page 1